ConfirmMDx was designed to be used in patients where there is a suspicion of prostate cancer but, despite undergoing TRUS biopsy, have not been appropriately diagnosed (due to the random nature of the TRUS biopsy). This problem becomes further problematic by the fact that prostate cancer is often a disease that occurs in more than one area of the prostate. Individuals presenting with risk factors, including abnormal DRE, elevated/rising prostate specific antigen (PSA), elevated/high risk biomarkers such as SelectMDx, in combination with one or multiple negative/atypical prostate biopsies may benefit from a ConfirmMDx test. By testing for the presence of hypermethylation (which is when certain molecules bind to areas of the genetic code (DNA) that have been shown to be precursors to initiating/promoting prostate cancer) of 3 biomarkers from your benign/atypical prostate tissue, your health care provider may be able to determine which area(s) of the prostate may be “hot spots” for prostate cancer, subsequently targeting these zone(s) of suspicion at the time of repeat biopsy.
This section is a visual representation for which biomarkers are positive or negative for DNA methylation.
DNA Methylation Result: This section describes whether your ConfirmMDx test was positive or negative for methylation. Below these results will be your approximate risk of finding some form of prostate cancer upon repeat biopsy (in this case, 88%). The test also reports the approximate risk for high grade (greater than or equal to Gleason 7) vs. low grade (Gleason 6) prostate cancer around the area where methylation was present. In combination with your health care provider's advice, ConfirmMDx may be useful in aiding your health care provider in deciding to do another biopsy, as well as determining specific areas or "hot spots" in the prostate that should be targeted upon repeat biopsy in an attempt to avoid the potential for additional false negative results.
Distribution of DNA Methylation Diagram: This section describes where the positive area or areas of methylation were found within your prostate. The base ("back") of the prostate is located closest to the bladder, while the apex ("front") of the prostate is where the penile urethra begins (tube that carries urine/semen).
Statistical Section: This section describes the statistical properties and how the ConfirmMDx test was validated. Basically, if the test has excellent ability to predict if there is cancer in the area based on hypermethylation, it will have an AUC of 1. If it has a poor ability to predict if there is cancer in the area based on hypermethylation, it would have a AUC of less than or equal to .50. The ConfirmMDx test has an AUC of .76, meaning it has a good predictive ability to predict if there is cancer in an area based on the hypermethylated tissue. The 95% confidence interval of .67-.84 shows the AUC range where 95% of this population studied fell in to (with the lowest of 64% accuracy to the highest of 84% accuracy).
DNA Methylation Result: This section describes whether your ConfirmMDx test was positive or negative for methylation. At the top of the table, you will notice 3 different methylation sites, GSTP1, APC, and RASSF1. Each of these genomic markers have been found to have the following association with prostate cancer.
GSTP1: Has been shown to be strongly correlated with prostate cancer. This biomarker, when hypermethylated, loses its ability to detoxify molecules which can damage your genetic code (DNA). This has been shown in research to cause an inflammatory response and potentially create lesions which are believed to be precursors to prostate cancer.
APC: Has been shown in research to be a gene that suppresses the cell from becoming cancerous (known as a tumor suppressor gene). When molecules bind to your genetic code (DNA), it can create errors in that code which can turn the APC gene off. When this occurs, the silencing of APC can lead to other important cell pathways to be turned off. This silencing of APC has been shown to be present in populations of patients with prostate cancer.
RASSF1: Has been shown in research to be a gene that suppress the cell from becoming cancerous (known as a tumor suppressor gene). It is believed that hypermethylation of this biomarker deactivates RASSF1s ability to stop normal cell division, thereby opening a pathway for the cell to become malignant.
Overall, if your benign or atypical prostate tissue has signs of methylation, it may indicate that there is a prostate cancer very close by. This phenomenon is known as the "halo effect," and has been shown in research to be identified by the ConfirmMDx test. Because of this, the ConfirmMDx test, in combination with your doctor's guidance, may be useful in understanding which area(s) of your prostate may need to be targeted upon re-biopsy.